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Table 3 Brazilian license situation, indications for neonates and off–label use in neonates in Brazil

From: Off-label use and harmful potential of drugs in a NICU in Brazil: A descriptive study

   MICROMEDEX BNFC 2012–2013  
  n (%) Indicated (%) Not (%) NI (%) Indicated (%) Not (%) NI (%) Most frequent drugs (neonates)
Licensed 329 (19.1) 78.7 21.3 -- 75.4 24.6 -- domperidone (59)a,c, vancomycin (55), pulmonary surfactant (49), phytomenadione (47), furosemide (29), epinephrine (26)
Unlicensed 38 (2.2) 36.8 7.9 55.3 47.4 -- 52.6 tricalciumphosphate (18)b,d, alprostadil (2), biotin (2), L-carnitine (2), riboflavin (2), thiamine (2)
Off-label 1358 (78.7) 64.8 22.9 12.3 90.6 3.0 6.4  
Age 869 (50.4) 55.6 33.0 11.4 87.8 2.8 9.4 heparin (97), fentanyl (92), multivitamins without minerals (91)b, aminophylline (87), ranitidine (53), metamizole (37)a,d, cefepime (31)a,d, omeprazole (29)a
Dose/frequency 345 (20.0) 82.9 1.7 15.4 98.8 1.2 -- gentamicin (110), ampicillin (108), amikacin (36), vancomycin (15), midazolam (3), ampicillin/sulbactam (5)
Age, pharmaceutical form 23 (1.3) 34.8 65.2 -- 95.7 4.3 -- spironolactone (7), methadone (6), captopril (3), propranolol (2), sildenafil (2)
Age, route of administration 29 (1.7) 48.3 -- 51.7 51.7 48.3 -- multivitamins without minerals (15)b, mineral oil (14)b,c
Route of administration 61 (3.5) 96.7 3.3 -- 96.7 3.3 -- phytomenadione (59), nystatin (2)a,c
Age, form, route of administration 14 (0.8) 100.0 -- -- 100.0 -- -- aminophylline (14)
Age, dose/frequency 8 (0.5) 100.0 -- -- 100.0 -- -- aminophylline (8)
Indication, pharmaceutical form, route of administration 6 (0.3) 100.0 -- -- 100.0 -- -- epinephrine (6)
Age, indication, pharmaceutical form 1 (0.1) 100.0 -- -- 100.0 -- -- acetylsalicylic acid (1)a
Dose/frequency, pharmaceutical form 2 (0.1) 100.0 -- -- 100.0 -- -- furosemide (1), levothyroxine (1)
Total 1725 (100.0) 66.8 22.3 10.9 86.8 7.1 6.1  
  1. NI No information
  2. aNot indicated by Micromedex
  3. bNot found in Micromedex
  4. cNot indicated by BNFC
  5. dNot found in BNFC